RecruitingNot ApplicableNCT07516964

SLIT ABS: Study on Patients With Autoimmune Podocytopathy

Validation and Implementation of Diagnostic Techniques for the Detection of Circulating Factors in Patients With Autoimmune Podocytopathy


Sponsor

Meyer Children's Hospital IRCCS

Enrollment

50 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Nephrotic syndrome is a kidney condition that mainly affects children and is characterized by high levels of protein in the urine, low levels of protein in the blood, and swelling. While many children respond well to steroid treatment, a large proportion experience relapses or become dependent on therapy. In some cases, the disease does not respond to standard treatments and may progress to chronic kidney disease. Recent research suggests that, in addition to genetic factors, immune system mechanisms may play a key role in the development and progression of nephrotic syndrome. In particular, some patients produce autoantibodies against nephrin, an essential protein of the kidney filtration barrier. These autoantibodies may be associated with disease activity and treatment response. The aim of this study is to investigate the presence of anti-nephrin autoantibodies in children with nephrotic syndrome and to better understand their role in disease mechanisms and clinical outcomes.The study will also explore the presence of other autoantibodies targeting components of the glomerular filtration barrier. The study will use advanced laboratory techniques, including blood tests and detailed analysis of kidney biopsy samples, to identify these antibodies and their relationship with kidney structure and function. By integrating laboratory findings with clinical data, this study aims to improve the understanding of nephrotic syndrome and support the development of more personalized diagnostic and therapeutic strategies, with the goal of improving patient outcomes and reducing unnecessary or ineffective treatments.


Eligibility

Min Age: 0 YearsMax Age: 99 Years

Inclusion Criteria6

  • Pediatric and adult patients with a diagnosis of podocytopathy
  • Patients with nephrotic syndrome and/or histological diagnosis of minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), collapsing glomerulopathy (CG), or diffuse mesangial sclerosis (DMS)
  • Both newly diagnosed (incident) patients and patients already under follow-up at participating centers
  • Availability of clinical data from medical records (including paper and/or electronic records, laboratory reports, and discharge summaries)
  • Availability of biological samples (e.g., blood and/or renal biopsy), if collected as part of routine clinical care
  • Signed informed consent by the patient or legal guardian (and assent when applicable)

Exclusion Criteria2

  • Refusal or inability of the patient, parents, or legal guardian to provide informed consent
  • Lack of sufficient clinical data or unavailable biological samples required for the study

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Interventions

OTHERSerum and renal tissue analysis

Analysis of serum and renal biopsy material collected as part of routine clinical care. Laboratory procedures include ELISA assays for the detection of anti-nephrin and/or others anti-slit antibodies and advanced imaging techniques, such as high-resolution confocal microscopy and STED microscopy, performed for research purposes


Locations(14)

Mayo Clinic

Rochester, Minnesota, United States

Ludwig-Maximilians Universitat

München, Germany

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

Meyer Children's Hospital IRCCS

Florence, FIRENZE, Italy

IRCCS Azienda Ospedaliero - Universitaria

Bologna, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Ospedale S. Giovanni di Dio

Florence, Italy

IRCCS Istituto Giannina Gaslini

Genova, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedale Santo Stefano

Prato, Italy

Azienda USL - IRCCS

Reggio Emilia, Italy

Hospital General de México, Mexico City

Mexico City, Mexico

Bellvitge University Hospital

Barcelona, Spain

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NCT07516964


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